|
A third study evaluated single, rising doses of NASONEX Nasal Spray, 50 mcg (1000, 2000, and 4000 mcg/ day), orally administered mometasone furoate (2000, 4000, and 8000 mcg/ day), orally administered dexamethasone (200, 400, and 800 mcg/ day), and placebo (administered at the end of each series of doses) in 24 male volunteers. Dose administrations were separated by at least 72 hours. Determination of serial plasma cortisol levels at 8 AM and for the 24-hour period fol-lowing each treatment were used to calculate the plasma cortisol area under the curve (AUC0-24). In addition, 24-hour urinary-free cortisol levels were collected prior to ini-tial treatment administration and during the period immediately following each dose. No statistically significant decreases in the plasma cortisol AUC, 8 AM cortisol levels, or 24-hour urinary-free cortisol levels were observed in volunteers treated with either Nasal Spray, 50 mcg or oral mometasone, as compared with placebo treatment. Conversely, nearly all volunteers treated with the three doses of dexamethasone demonstrated abnormal 8 AM cortisol levels (defined as a cortisol level <10 mcg/ dL), reduced 24-hour plasma AUC values, and decreased 24-hour urinary-free cortisol lev-els, as compared to placebo treatment. Three clinical pharmacology studies have been conducted in pediatric patients to assess the effect of mometasone furoate nasal spray, on the adrenal function at daily doses of 50, 100, and 200 mcg vs placebo. In one study, adrenal function before and after 7 consecutive days of treatment was assessed in 48 pediatric patients with aller-gic rhinitis (ages 6 to 11 years) by measuring morning plasma cortisol and 24-hour urinary-free cortisol levels. Text Continues Below
Mometasone furoate nasal spray, at all three doses, was not associated with a statistically significant decrease in mean plasma cortisol levels or a statistically significant decrease in the 24-hour urinary-free cortisol levels com-pared to placebo. In the second study, adrenal function before and after 14 consecu-tive days of treatment was assessed in 48 pediatric patients (ages 3 to 5 years) with allergic rhinitis by measuring plasma cortisol levels following a 30-minute Cortrosyn infusion. Page: << Prev | 1 | 2 | 3 | 4 | 5 | Next >>
|
.gif)
